BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD

FDA 510(k)

FDA Class 2 ·Dental

POLYCORE

FDA 510(k)

ProSeal™ Closed System Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

ProSeal™ Injector Plus (Model no. 421050)

FDA 510(k)

FDA Class 2 ·General Hospital

iSR’obot Mona Lisa 2.0

FDA 510(k)

FDA Class 2 ·Radiology

VISIOPAL 75

FDA 510(k)

KRYPTOX-ROUND SEGMENT BIFOCAL

FDA 510(k)

iRAD

FDA 510(k)

FDA Class 2 ·Radiology

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Instalief

FDA 510(k)

FDA Unclassified ·Unknown

Safety Subcutaneous Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital

MEDLINX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ToxiSeal™ Vial Adaptor

FDA 510(k)

FDA Class 2 ·General Hospital

Everion+ System

FDA 510(k)

FDA Class 2 ·Cardiovascular

iSR'obot Biopsy Kit

FDA 510(k)

FDA Class 2 ·Radiology

TIGR SURGICAL MESH , MODEL WK-6

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iSR'obot MRI-US Fusion

FDA 510(k)

FDA Class 2 ·Radiology